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Abstract Details

Eptinezumab for the Prevention of Episodic Migraine Through 1 Year: Results from the Phase 3 PROMISE-1 (Prevention of Migraine via Intravenous Eptinezumab Safety and Efficacy?1) Trial
Headache
S38 - Headache: Clinical Trials II (1:22 PM-1:33 PM)
003
Eptinezumab, an anti-CGRP monoclonal antibody, selectively inhibits the CGRP ligand, which plays an important role in migraine pathophysiology. 

To evaluate the efficacy and safety of eptinezumab for episodic migraine (EM) prevention through 1 year.

Eligible adults (EM, ICHD-II) were randomized to eptinezumab 30mg, 100mg, 300mg, or placebo, administered intravenously every 12 weeks for 4 infusions. The primary endpoint was change from baseline in mean monthly migraine days (MMDs) over Weeks 1-12. Key secondary endpoints included: ≥75% migraine responder rates (RRs) over Week 1-4; ≥75% and ≥50% migraine RRs over Weeks 1-12.

Baseline mean MMDs were ~8.5 across groups in the efficacy population (N=888). In 100mg-treated patients, changes from baseline in MMDs were -3.9 (Months1-3; p=0.018), -4.5 (Months4-6), -4.7 (Months7-9), and -4.5 (Months10-12). The ≥75% migraine RRs were: 30.8% (p=0.011), 22.2% (NS), 33.5%, 40.3%, and 39.4% over Months1, 1-3, 4-6, 7-9, and 10-12, respectively. The ≥50% migraine RRs were: 49.8% (Months1-3; p=0.009), 62.0% (Months4-6), 63.8% (Months7-9), and 64.7% (Months10-12).

In 300mg-treated patients, changes from baseline in MMDs were -4.3 (Months1-3; p<0.001), -4.8 (Months4-6), -5.1 (Months7-9), and -5.3 (Months10-12). The ≥75% migraine RRs were: 31.5% (p=0.007), 29.7% (p<0.001), 40.1%, 43.2%, and 54.1% over Months1, 1-3, 4-6, 7-9, and 10-12, respectively. The ≥50% migraine RRs were: 56.3% (Months1-3; p<0.001), 65.3% (Months4-6), 69.8% (Months7-9), and 69.8% (Months10-12).

In placebo-treated patients, the change from baseline in MMDs was -3.2 (Months1-3), -3.8 (Months4-6), -4.0 (Months7-9), and -4.1 (Months10-12). The ≥75% migraine RRs were: 20.3% (Month1), 16.2% (Months1-3), 16.2% (Months4-6), 29.7% (Months7-9), and 39.6% (Months10-12). The ≥50% migraine RRs were: 37.4% (Months1-3), 51.4% (Months4-6), 58.1% (Months7-9), and 55.4% (Months10-12).

Treatment-emergent adverse event rates were similar between groups.

Eptinezumab reduced MMDs over the first 3 months with sustained or incremental reductions achieved with additional infusions. Migraine RRs were greater with eptinezumab vs placebo across dosing intervals.

Authors/Disclosures
Roger Cady, MD (RK Consulting, LLC)
PRESENTER
Dr. Cady has received personal compensation for serving as an employee of Lundbeck. Dr. Cady has stock in Alder Biopharmaceutical.
Joel R. Saper, MD, FAAN (MHNI) No disclosure on file
Kerri L. Wilks, MD, CPI No disclosure on file
George Chakhava, MD, PhD (Multiprofile Clinic Consilium Medulla) Prof. Chakhava has nothing to disclose.
Barbara Schaeffler No disclosure on file
David M. Biondi, DO, FAAN Dr. Biondi has received personal compensation for serving as an employee of Cohen Veterans Bioscience, Inc. Dr. Biondi has received personal compensation for serving as an employee of Alder Biopharmaceuticals, Inc. Dr. Biondi has received stock or an ownership interest from Johnson & Johnson . The institution of Dr. Biondi has received research support from US Department of Defense .
No disclosure on file
Jeff Smith (Alder Biopharmaceuticals) No disclosure on file